Chronic Moderate Sleep Restriction in Older Adults (MSSS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2012 by University of California, Los Angeles
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Michael Irwin, M.D., University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01642719
First received: July 13, 2012
Last updated: July 17, 2012
Last verified: July 2012
  Purpose

Higher rates of mortality have been found both in short sleepers (< 6 hr/night) and long sleepers (> 8 hr/night), but there has been little experimental investigation of the effects of chronic, moderate sleep loss in long or average sleepers. Some scientists argue that older adults might be particularly vulnerable to negative effects of sleep loss, whereas other scientists argue that many older adults spend too much time in bed, and that moderate reduction of time-in-bed could help increase the quality of their sleep, and could even promote health and longevity, particularly in long sleepers. At 4 sites across the US, we will conduct a large (200 people), randomized, controlled, 5- year study to examine whether a 1-hour reduction of time spent in bed for 12 weeks has negative or positive effects on multiple health-related outcomes, including inflammation, sleepiness, body weight, mood, glucose regulation, quality of life, incidence of illness, and incidence of automobile accidents in older long sleepers as compared to older average sleepers.


Condition Intervention Phase
Sleep Disturbance
Aging
Behavioral: Sleep restriction
Behavioral: Non-sleep restriction
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Chronic Moderate Sleep Restriction in Older Long Sleepers and Older Average Sleepers

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Change in adherence to sleep restriction from baseline [ Time Frame: Daily for 12 weeks ] [ Designated as safety issue: No ]
    Evaluation of ability to adhere to a 60 min time-in-bed restriction over 12 weeks


Secondary Outcome Measures:
  • Change in sleepiness from baseline [ Time Frame: Every week for 12 weeks ] [ Designated as safety issue: No ]
    Evaluation of sleepiness by weekly self-report for 12 weeks

  • Change in health functioning from baseline [ Time Frame: Every 2 weeks for 12 weeks ] [ Designated as safety issue: No ]
    Evaluation of health functioning by self-report for 12 weeks

  • Change in sleep quality from baseline [ Time Frame: Every month for 12 weeks ] [ Designated as safety issue: No ]
    Evaluation of sleep quality by self report every month for 12 weeks

  • Change in measures of cognitive performance from baseline [ Time Frame: Every month for 12 weeks ] [ Designated as safety issue: No ]
    Evaluation of cognitive performance including standardized tasks to assess attention every month for 12 weeks

  • Change in physical activity from baseline [ Time Frame: Every 8 weeks for 12 weeks ] [ Designated as safety issue: No ]
    Evaluation of physical activity by waist actigraphy and self-report every 8 weeks for 12 weeks

  • Markers of glucose metabolism [ Time Frame: Baseline and at 12 weeks ] [ Designated as safety issue: No ]
    Evaluation of glucose metabolism by fasting glucose, glucose tolerance test, and hemoglobin A1C at baseline and again at 12 weeks

  • Change in depressive symptoms from baseline [ Time Frame: Every 2 weeks for 12 weeks ] [ Designated as safety issue: No ]
    Evaluation of depressive symptoms by self-report every 2 weeks for 12 weeks

  • Markers of inflammation [ Time Frame: Baseline and at 12 weeks ] [ Designated as safety issue: No ]
    Evaluation of cellular and genomic markers of inflammation at baseline and at 12 weeks

  • Change in fatigue from baseline [ Time Frame: Every 2 weeks for 12 weeks ] [ Designated as safety issue: No ]
    Evaluation of fatigue by self-report every 2 weeks for 12 weeks


Estimated Enrollment: 200
Study Start Date: July 2012
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Non-sleep restriction
Participants will be asked to maintain fixed bedtimes, wake-times, times in bed, and napping, consistent with each person's average baseline
Behavioral: Non-sleep restriction
Participants will be asked to maintain fixed bedtimes, wake-times, times in bed, and napping, consistent with each person's average baseline.
Experimental: Sleep restriction
Participants will be asked to reduce their time in bed (TIB) by 60 min below their median baseline TIB, and to maintain this sleep restriction every night for 12 weeks. For example, if they spend 9 hr TIB during baseline, they will reduce their TIB to 8 hr.
Behavioral: Sleep restriction
Participants will be asked to reduce their time in bed (TIB) by 60 min below their median baseline TIB, and to maintain this sleep restriction every night for 12 weeks.

Detailed Description:

Epidemiologic studies have consistently shown that self -reported sleep durations of <7 hr and >8 hr are associated with increased mortality and morbidity. The risks associated with short sleep are consistent with a vast experimental literature indicating detrimental effects of profound sleep restriction. However, there has been little study of chronic moderate sleep restriction, which is far more common, and thus more important from a public health standpoint. The risks associated with long sleep have scarcely been experimentally examined, though epidemiological data suggest sleep restriction might promote health/longevity in long sleepers. Older adults might be more vulnerable than young adults to negative effects of further sleep impairment, perhaps particularly via inflammatory mechanisms. Negative effects might be at least as evident in long sleepers as in average sleepers if long sleep reflects underlying morbidity, as many have posited. On the other hand, older adults might tolerate (or benefit) from moderate sleep restriction. Older adults often tend to spend excessive time in bed (TIB), particularly long sleepers, and extra TIB could contribute to age-related sleep fragmentation and morbidity, which could be ameliorated with modest TIB restriction. The aims of this study are: (1) to examine the ability of older long sleepers and older average sleepers to adhere to 60 min TIB restriction; and (2) to contrast effects of 12 weeks of 60 min TIB restriction on health-related measures in older long vs. average sleepers. One hundred older adults (ages 60-80 yr) who report sleeping 8-9 hr per night and 100 adults of the same age range who report sleeping 6-7.25 hr per night will be examined at 4 experimental sites over 5 years. Following a 2-week baseline, participants will be randomly assigned to one of two 12-week treatment groups. (1) A sleep restriction group (n=60 long sleepers and n=60 average sleepers) will be assigned to a fixed sleep- wake schedule, in which time in bed is reduced precisely 60 min below each participant's baseline time in bed (TIB). (2) A control group (n=40 long sleepers and n=40 average sleepers) will have no sleep restriction, but will also follow a fixed sleep schedule. Sleep will be assessed continuously with actigraphy and a daily diary. Questionnaires will be answered. Measures will include body weight, glucose tolerance, sleepiness, depression, quality of life, psychomotor vigilance, incidence of automobile accidents, incidence of illness, and multiple markers of inflammation. Physical exams during weeks 2 and 6 of the intervention and a study ombudsman will further monitor potential adverse effects. Follow-up assessments will be conducted for 12 months. The proposed clinical trial will provide the most comprehensive Phase 1 assessment of risks and benefits of chronic moderate TIB restriction ever conducted.

  Eligibility

Ages Eligible for Study:   60 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 60-80 years of age
  • Sleeping an average of 8-9 hr per night for long sleeper (or)
  • Sleep an average of 6.0-7.25 hr per night for short sleepers
  • Able to designate a study partner that can speak on their behalf throughout the course of the study.

Exclusion Criteria:

  • Reported average sleep duration of < 8.0 hr or > 9.0 hr for longer sleepers
  • Reported average sleep duration of < 6 hr or > 7.25 hr for the average sleepers
  • Spending > 30 min time in bed in the morning and/or night outside of the major sleep period (e.g., watching tv)
  • Expected change in usual sleep duration in the near future (e.g., change in work schedule)
  • Reported average napping of > 2 naps/day or total nap duration of > 90 min/day;
  • Recent shift-work (previous 2 months) or travel across multiple time zones (previous 4 weeks), or plans for performing shift-work or transmeridian travel during the study time period;
  • Severe sleep apnea (apnea-hyponea index of greater or equal 15);
  • Obesity (body mass index ≥35);
  • High daytime sleepiness (Epworth Sleepiness Scale ≥ 10);
  • Depression (Quick Inventory of Depressive Sympotomology > or equal to 16);
  • Use of hypnotics or other drugs prescribed to promote sleep;
  • Alcohol dependence or drug use;
  • Any medical, neurologic, or psychiatric illness causing long sleep;
  • Factors associated with significant changes in inflammation, including several medical disorders (e.g., rheumatoid arthritis), medications (e.g., steroids) and current smoking;
  • Any health or mental condition that would contraindicate participation in the rigors of the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01642719

Locations
United States, Arizona
University of Arizona Recruiting
Tucson, Arizona, United States, 85721-0000
Contact: Richard R. Bootzin, Ph.D.    520-621-5705    Bootzin@U.Arizona.edu   
Principal Investigator: Richard R. Bootzin, Ph.D.         
United States, California
UCLA Cousins Center for Psychoneuroimmunology Recruiting
Los Angeles, California, United States, 90095
Contact: Michael Irwin, M.D.    310-825-8281    mirwin1@ucla.edu   
Contact: Fabio Catao, M.D.    (310) 825-8281    fcatao@mednet.ucla.edu   
Principal Investigator: Michael R Irwin, M.D.         
United States, New York
SUNY Downstate Medical Center Recruiting
Brooklyn, New York, United States, 12201-0009
Contact: Girardin Jean-Louis, Ph.D.    718-270-2716    jeanlouisg@yahoo.com   
Principal Investigator: Girardin Jean-Louis, Ph.D.         
United States, South Carolina
University of South Carolina Recruiting
Columbia, South Carolina, United States, 29208-0000
Contact: Shawn D. Youngstedt, Ph.D.    803-777-7296    SHAWN YOUNGSTEDT <SYOUNGST@mailbox.sc.edu>   
Principal Investigator: Shawn D. Youngstedt, Ph.D.         
Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: Shawn Yougstedt, Ph.d. University of South Carolina
Principal Investigator: Richard Bootzin, Ph.D. University of Arizona
Principal Investigator: Michael Irwin, M.D. University of California, Los Angeles
Principal Investigator: Giardin Jean-Louis, Ph.D. State University of New York - Downstate Medical Center
  More Information

Additional Information:
No publications provided

Responsible Party: Michael Irwin, M.D., Director, Cousins Center for Psychoneuroimmunology; Cousins Professor,Department of Psychiatry, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01642719     History of Changes
Other Study ID Numbers: 1 R01 HL095799-01A2, 1R01HL095799-01A2
Study First Received: July 13, 2012
Last Updated: July 17, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Los Angeles:
Sleep disturbance
Aging
Sleep restriction
Health status
Glucose tolerance
Inflammation

Additional relevant MeSH terms:
Sleep Disorders
Dyssomnias
Parasomnias
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders

ClinicalTrials.gov processed this record on July 22, 2014